CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report

Kits containing Covidien Force TriVerse Electrosurgical Devices recalled

Covidien is recalling Kits containing Covidien Force TriVerse Electrosurgical Devices, distributed nationwide in the US. The recall was initiated on 10 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 0218917589 0218909457 0218940986 0219010003 0218954164 0218909455 0218938181 0219010001 0219015316 0218909452 0218953902 0219010002 0218862144 0218909456 0218953120 0219010000 0218909458 0218909460 0218917904 0219010004 0218909454 0218917602 0218962165 0219010005 0218909453 0218917603 0219013846 0219009999 0218909459 0218917588 0219013847 0218907363 0218953822 0218908405 0218953514 0218813863 0218782098 0218836471 0218836472 0218836473 0218836474 0218836470 0218863976 0218836468 0218836475 0218851370 0218836469 0218879245 0218836478 0218861244 0218927160 0218926415 0218907609

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1447-2020
FDA event ID: 84991
Recalling firm: Covidien, Mansfield, MA
Classification: Class II
Status: Terminated
Recall initiated: 10 Feb 2020
FDA classified: 5 Mar 2020
Reported: 11 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

10 Feb 2020	Recall initiated by company
5 Mar 2020	Classified by FDA	+24 days
11 Mar 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT02 LAR28PLN MGBGLOCX1 SGGLOCX1 HEMICX1 LAPWL STOM25PL TGGLOCX1 TIROIDEKIT UROCYSPL VAGHCJ VATSZD2 VGYN VMED VMED3 ZGVATS1

Where it was distributed

Nationwide domestic distribution. Foreign distribution to Australia, Canada, Austria Belgium Canary Islands Czech Republic Denmark Finland France Germany Greece Hungary Italy Jordan Kazakhstan Kenya Lithuania Luxembourg North Macedonia Poland Portugal Reunion Romania Russian Federation Serbia Slovakia Spain Sweden Switzerland United Kingdom No U.S. distribution of Kits. Foreign distribution in EMEA only. (Europe, Middle East and Africa.)

Nationwide

Questions about this recall

Is Kits containing Covidien Force TriVerse Electrosurgical Devices recalled?

Yes. Covidien recalled Kits containing Covidien Force TriVerse Electrosurgical Devices on 10 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1447-2020.

Why was it recalled?

Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.

Which lots are affected?

Lots 0218917589 0218909457 0218940986 0219010003 0218954164 0218909455 0218938181 0219010001 0219015316 0218909452 0218953902 0219010002 0218862144 0218909456 0218953120 0219010000 0218909458 0218909460 0218917904 0219010004 0218909454 0218917602 0218962165 0219010005 0218909453 0218917603 0219013846 0219009999 0218909459 0218917588 0219013847 0218907363 0218953822 0218908405 0218953514 0218813863 0218782098 0218836471 0218836472 0218836473 0218836474 0218836470 0218863976 0218836468 0218836475 0218851370 0218836469 0218879245 0218836478 0218861244 0218927160 0218926415 0218907609

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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